FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Siemens Mevatron M-2 6740 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position)Model Number: 9401506, Siemens Medical Solutions, Concord, CA 94520
- Recall number
- Z-0679-2008
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Siemens Mevatron M-2 6740 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position)Model Number: 9401506, Siemens Medical Solutions, Concord, CA 94520
- Status
- Terminated
- Initiated
- 2007-08-07
- Posted
- 2008-02-14
- Terminated
- 2010-12-01
- Reason
- Incorrect field size -- Products manufactured prior to 1999 may experience jaw field size errors during interlock resulting in potential mistreatment if a light field check is not performed. This problem is present in machines with serial numbers less than 3094, as they do not contain redundant sensors for jaw position.
- Root cause
- Device Design
- Action
- The firm has sent consignees a Customer Safety Advisory Notice on August 7, 2007 informing them that a misplacement of the X and/or Y jaws can occur if interlock #51 Jaw Field Position is asserted and then cleared with the left-hand key rest. The firm recommends that if an interlock issue is encountered tha treatment of the patient be discontined until this issue is resolved.
- Quantity
- 29 units
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- Serial Numbers: 2011, 2093, 2156, 2171, 2177, 2186, 2211, 2227, 2247, 2254, 2271, 2343, 2349, 2367, 2369, 1969, 2164, 2267, 2331, 2389, 2435, 2417, 2161, 2257, 2295, 2325, 2352, 2355, and 2401
- 510(k) numbers
- ["K882729"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 2937457
- Firm city
- Concord
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28